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| ID | Type | Description | Link |
|---|---|---|---|
| SU-09022010-6791 | Other Identifier | Stanford University | |
| VAR0047 | Other Identifier | OnCore Number |
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The purpose of the study was to conduct a pilot test of new tracers ([18F]FPRGD2 and [18F]FPPRGD2) to define normal tracer biodistribution (where the tracer goes), stability (how much metabolises), pharmacokinetics (how much stays in which organs and for how long), and radiation dosimetry (organ radiation dose). Healthy volunteers provided the normal biodistribution data.
The same radiopharmaceutical was also tested in breast cancer, glioblastoma multiform (brain cancer), and lung cancer.
The tracer [18F]FPRGD2 was not evaluated in this study. The protocol title was never amended to reflect this.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healty Volunteers | Other | Normal volunteers to receive 5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection. |
|
| Breast Cancer | Experimental | Breast cancer patients to receive 4 to 11 mCi F18-FPPRGD2 by IV injection. |
|
| Glioblastoma Multiform (brain) | Experimental | Glioblastoma multiform patients to receive 5 to14 mCi F18-FPPRGD2 by IV injection. |
|
| Lung Cancer | Experimental | Lung cancer patients to receive X to XX mCi F18-FPPRGD2 by IV injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F18-FPPRGD2 | Drug | Radiopharmaceutical administered for imaging, up to 14 mCi intravenous (IV). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tracer Dosimetry by Organ | Normal radiopharmaceutical biodistribution was analyzed visually to obtain dosimetry data in healthy volunteers. Organs with the highest radiation absorbed dose (dosimetry) are provided below. Dosimetry was calculated by drawing regions-of-interest around organs with visually appreciable radiopharmaceutical uptake greater than background and using organ-level internal dose assessment software from Vanderbuilt University (2003). Results are reported in mSv/MBq (milli-Sieverts per mega-Bequerel) which is a measurement of the mean absorbed radiation dose within an organ. | 5 hours |
| F18-FPPRGD2 Time-activity at Specified Timepoints | Radiopharmaceutical pharmacokinetics describe the change in radiopharmaceutical distribution in the body (from the blood to organs, tissues, cells) over time. Radiopharmaceutical pharmacokinetics are used to determine optimal imaging time, ie, when target activity (organ or cell of interest) is greater than background activity (blood). Optimal imaging time must also be balanced with tracer bio-metabolism and radioactive decay. F18-FPPRGD2 pharmacokinetics was measured in healthy volunteers to estimate optimal imaging time. Scans were used to visually identify regions of interest (organs of F18-FPPRGD2 accumulation), and detected radiation was plotted as a measurement over time. | 30, 60, and 90 minutes post-injection |
| Sensitivity of F18-FPPRGD2 PET/CT in Breast Cancer | Sensitivity is the ability of a test to correctly identify patients with the disease being investigated. In this instance, how well F18-FPPRGD2 PET/CT detects true-positive patients. Sensitivity is defined as [TP/ (TP+FN)], where TP= true positive, and FN = false negative. The outcome is reported as a percentage without dispersion. A higher percentage indicates a greater probability that a lesion identified based on scan results is cancerous, and a lower percentage indicates reduced confidence in that result. | 3 hours |
| Specificity of F18 FPPRGD2 PET/CT in Breast Cancer |
| Measure | Description | Time Frame |
|---|---|---|
| Glioblastoma Primary Tumor Response Assessed by CT Scan | Primary tumor response was assessed after 6 weeks of treatment as the change in tumor metabolism based on the maximum standardized uptake value (SUVmax) as determined by computed tomography (CT) scans. Decreased SUVmax correlates to a reduction of tumor metabolism, and is considered an indicator of primary tumor response. Reduction of SUVmax was determined as the change from baseline in uptake of F-18FPPRGD2. The outcome is reported as the mean difference from baseline to week 6, with standard deviation. |
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Inclusion Criteria:
Healthy volunteers:
Cancer subjects:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sanjiv Gambhir, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers | 5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection. |
| FG001 | Breast Cancer | 4 to 11 mCi F18-FPPRGD2 by IV injection |
| FG002 | Glioblastoma Multiform Patients | 5 to14 mCi F18-FPPRGD2 by IV injection |
| FG003 | Lung Cancer | X to XX mCi F18-FPPRGD2 by IV injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers | 5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection |
| BG001 | Breast Cancer Patients | 4 to 11 mCi F18-FPPRGD2 by IV injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tracer Dosimetry by Organ | Normal radiopharmaceutical biodistribution was analyzed visually to obtain dosimetry data in healthy volunteers. Organs with the highest radiation absorbed dose (dosimetry) are provided below. Dosimetry was calculated by drawing regions-of-interest around organs with visually appreciable radiopharmaceutical uptake greater than background and using organ-level internal dose assessment software from Vanderbuilt University (2003). Results are reported in mSv/MBq (milli-Sieverts per mega-Bequerel) which is a measurement of the mean absorbed radiation dose within an organ. | Per protocol, data were collected for this outcome from the Healthy Volunteers group only, and only those that completed all scans are included. | Posted | Mean | Standard Deviation | mSv/MBq | 5 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteers | 5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection | 0 |
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This study is a pilot study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrei Iagaru, MD | Stanford University | 6507362859 | aiagaru@stanford.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Specificity is the ability of a test to correctly identify patients who do not have the disease being investigated. In this instance, how well F18 FPPRGD2 PET/CT detects true-negative patients. Specificity is:
[TN/ (TN+FP)], where TN= true negative, and FP = false positive.
| an estimated average of 3 hours |
| Glioblastoma Primary Tumor Response Assessed by PET Scan | Primary tumor response was assessed after 6 weeks of treatment as the change in tumor metabolism based on the maximum standardized uptake value (SUVmax) as determined by positron emission tomography (PET) scans. Decreased SUVmax correlates to a reduction of tumor metabolism, and is considered an indicator of primary tumor response. Reduction of SUVmax was determined as the change from baseline in uptake of F-18FPPRGD2. The outcome is reported as the baseline and week 6 values, with standard deviation. | Baseline and Week 6 |
| Baseline and Week 6 |
| BG002 | Glioblastoma Multiforme | 5 to14 mCi F18-FPPRGD2 by IV injection |
| BG003 | Lung Cancer | X to XX mCi F18-FPPRGD2 by IV injection |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | F18-FPPRGD2 Time-activity at Specified Timepoints | Radiopharmaceutical pharmacokinetics describe the change in radiopharmaceutical distribution in the body (from the blood to organs, tissues, cells) over time. Radiopharmaceutical pharmacokinetics are used to determine optimal imaging time, ie, when target activity (organ or cell of interest) is greater than background activity (blood). Optimal imaging time must also be balanced with tracer bio-metabolism and radioactive decay. F18-FPPRGD2 pharmacokinetics was measured in healthy volunteers to estimate optimal imaging time. Scans were used to visually identify regions of interest (organs of F18-FPPRGD2 accumulation), and detected radiation was plotted as a measurement over time. | Per protocol, data were collected for this outcome from the Healthy Volunteers group only. 4/5 volunteers were able to complete all of the scans. 1/5 participant could only complete one of the four scans and was not included in pharmacokinetic calculations. | Posted | Mean | Standard Deviation | Percentage of tracer remaining in blood | 30, 60, and 90 minutes post-injection |
|
|
|
| Primary | Sensitivity of F18-FPPRGD2 PET/CT in Breast Cancer | Sensitivity is the ability of a test to correctly identify patients with the disease being investigated. In this instance, how well F18-FPPRGD2 PET/CT detects true-positive patients. Sensitivity is defined as [TP/ (TP+FN)], where TP= true positive, and FN = false negative. The outcome is reported as a percentage without dispersion. A higher percentage indicates a greater probability that a lesion identified based on scan results is cancerous, and a lower percentage indicates reduced confidence in that result. | Per protocol, data were collected for this outcome from the Breast Cancer Patients group only. In a per-lesion analysis, a total of 30 lesions were evaluated at PET/CT scanning with F18-FPPRGD2. | Posted | Number | percentage of sensitivity | 3 hours | Lesions | Lesions |
|
|
|
| Primary | Specificity of F18 FPPRGD2 PET/CT in Breast Cancer | Specificity is the ability of a test to correctly identify patients who do not have the disease being investigated. In this instance, how well F18 FPPRGD2 PET/CT detects true-negative patients. Specificity is: [TN/ (TN+FP)], where TN= true negative, and FP = false positive. | Per protocol, data were collected for this outcome from the Breast Cancer Patients group only. Other cohorts are not included, and the outcome was only assessed in the breast cancer cohort. | Posted | Number | percentage of specificity | an estimated average of 3 hours |
|
|
|
| Primary | Glioblastoma Primary Tumor Response Assessed by PET Scan | Primary tumor response was assessed after 6 weeks of treatment as the change in tumor metabolism based on the maximum standardized uptake value (SUVmax) as determined by positron emission tomography (PET) scans. Decreased SUVmax correlates to a reduction of tumor metabolism, and is considered an indicator of primary tumor response. Reduction of SUVmax was determined as the change from baseline in uptake of F-18FPPRGD2. The outcome is reported as the baseline and week 6 values, with standard deviation. | Per protocol, data were collected for this outcome from the Glioblastoma Multiforme group only. Participants in the Glioblastoma Multiforme group who completed the imaging schedule were included in the analysis. | Posted | Mean | Standard Deviation | SUVmax | Baseline and Week 6 |
|
|
|
|
| Secondary | Glioblastoma Primary Tumor Response Assessed by CT Scan | Primary tumor response was assessed after 6 weeks of treatment as the change in tumor metabolism based on the maximum standardized uptake value (SUVmax) as determined by computed tomography (CT) scans. Decreased SUVmax correlates to a reduction of tumor metabolism, and is considered an indicator of primary tumor response. Reduction of SUVmax was determined as the change from baseline in uptake of F-18FPPRGD2. The outcome is reported as the mean difference from baseline to week 6, with standard deviation. | Per protocol, data were collected for this outcome from the Glioblastoma Multiforme group only. Participants in the Glioblastoma Multiforme group who completed the imaging schedule were included in the analysis. | Posted | Mean | Standard Deviation | percentage change | Baseline and Week 6 |
|
|
|
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Breast Cancer Patients | 4 to 11 mCi F18-FPPRGD2 by IV injection | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Glioblastoma Multiforme | 5 to14 mCi F18-FPPRGD2 by IV injection | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | Lung Cancer | 5 to14 mCi F18-FPPRGD2 by IV injection | 0 | 4 | 0 | 4 | 0 | 4 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| Title | Measurements |
|---|---|
|